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Comparative effectiveness research: what to do when experts disagree about risks
Reidar K Lie1, Francis K L Chan2, Christine Grady3
1Department of Philosophy, University of Bergen, Sydnesplassen 12, 5020, Bergen, Norway. Reidar.lie@uib.no.
BMC Medical Ethics
|June 21, 2017
Summary
Ethics Review Committees (ERCs) should evaluate comparative effectiveness research by assessing expert disagreement, not just when evidence is unknown. This ensures accurate risk assessment for clinical trials.
Area of Science:
- Medical Ethics
- Clinical Research Oversight
- Health Services Research
Background:
- Comparative effectiveness research (CER) compares existing medical standards of care.
- Ethical considerations in CER are increasingly important.
- Ethics Review Committees (ERCs) face challenges in evaluating CER risks.
Purpose of the Study:
- To reframe the ethical evaluation of CER beyond the "nothing is known" criterion.
- To provide guidance for ERCs on assessing risks in CER, particularly when expert opinions diverge.
- To highlight the importance of expert disagreement in risk assessment for clinical trials.
Main Methods:
- Discussion of the prominent debate focus in CER justification.
- Analysis of the shift from "nothing is known" to expert disagreement.
- Introduction of a case study to illustrate expert disagreement in CER.
- Framework development for ERC evaluation of expert opinions.
Main Results:
- The "nothing is known" criterion is potentially misleading for CER evaluation.
- Expert disagreement is a critical factor in determining the ethical acceptability of CER.
- ERCs must assess the basis and strength of evidence underlying expert opinions.
Conclusions:
- ERCs have a duty to evaluate the spectrum of expert opinions to judge study risks.
- Assessing expert disagreement is crucial for assigning appropriate risk levels to clinical trials.
- Clinical trial monitoring can mitigate potential risks associated with participant enrollment.
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